22 results
·
30ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526827837·***DISC*LEVAMED ANKLE SUPPORT BLACK I
MODIFICATION TO: AGILITY STEERABLE GUIDEWIRES
FDA 510(k)
FDA Class 2
·Cardiovascular
Zirlux
FDA UDI
HENRY SCHEIN, INC.·H65890105110·Zirlux Titanium Abutment 3 mmH compatible with:...
TiWAVE C Cervical Cage System
FDA UDI
Kalitec Direct LLC·B07320K0100110·Handle, Universal Slim with Depth Stops
PACK SHANNON BURRS LG20 MM STERILE DIA 2.0 X LENGTH 75 MM
FDA Adverse Event
Malfunction
·IN2BONES SAS·Product code GFF·February 3, 2026
O-LAS OPHTHALMIC PHOTODISRUPTOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MODIFICATION TO ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, POWERCORD, ARTHROWANDS AND SPINE WANDS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NA
FDA UDI
STRYKER CORPORATION·07613153000426·4.0mm Round Solid Carbide Bur Medium
TiNano
FDA UDI
AURORA SPINE, INC.·B5211050105110·DISCOVERY Cervical Interbody Fusion System, 14m...
LYNX
FDA UDI
HNM TOTAL RECON LLC·00841742112138·LYNX Distal Humeral Locking Plate, Medial, Ti -...
NA
FDA UDI
STRYKER CORPORATION·04546540755063·10.5MM GRAFT SIZING GAUGE
BE-VKMO 70000 #QUADR-I HMO70000+VHK7100
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTZ·January 5, 2015
BE-VKMO 70000 #QUAD-I HMO70000+VHK7100
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTZ·January 5, 2015
BE-VKMO 70000 #QUADR-I HMO70000+VHK7100
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTZ·January 5, 2015
BE-VEMO 7000 #QUADR-I HMO70000+VHK7100
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTZ·January 5, 2015
QUATTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·March 14, 2013
UNKNOWN ZIMMER KNEE
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code JWH·March 1, 2011
GUGLIELMI DETACHABLE COILS (GDC)
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORP.·Product code HCG·February 11, 2008
ELITE 12CM ANGLED ATTACHMENT
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code HBE·October 28, 2020
Upper roller bracket (part number 1088370) for the Gen2 gantry enclosure for the Radixact Treatment Delivery System.
FDA Enforcement
Class II
·Completed·Accuray Incorporated·September 6, 2023